Services

SK Consulting offers QA Auditing Services, Consultation for Quality Management Systems and Training

Phase I – Phase IV clinical studies as well as Late Phase Studies (Post Marketing Authorisation Studies e.g. PASS/PAES) for medicines and medical devices. business partners putting puzzle together

Type of Audits

  • Vendor Audits (CRO, IWRS/IVRS, Central Laboratory, MRI, IMP Distribution Centre, IMP Warehouse, etc.)
  • Documentation Audits  (CSR, Master File (TMF, ISF, Submission Files, etc.)
  • Investigational Site Audits
  • Phase I Unit
  • Data Management Audits
  • Triggered Audits (“For Cause” Audits)
  • Pre-Inspection Preparation Audits
  • Academic Trials
  • Non-interventional studies

        Pharmacovigilance System (GVP Modules)

  • System Audits (Assessments) within the company
  • Partner / External Service Providers (ESP) Audits
  • Pre-Inspection Assessments (internally)
  • Risk-Assessment

       Independent Ethic Committee

  • Assessing structure and organisation in IEC/IRB
  • Review of Standard Operating Procedures and gap analysis
  • Support in setting up a regulated working area with a quality management system
  • Training of employees in administration/ICH GCP

Each audit will be followed by a comprehensive and confidential report. Reports and supporting documentation will be managed according to the SOPs of the client or if requested according to SK Consulting SOPs and working tools. If requested by the client, involvement in follow-up activities of each assessment/audit (i.e. CAPA review, acceptance, follow-up steps) can be arranged. Review of the first CAPA response is included in the offer.

Training

  • Basic and Advanced GCP Training
  • Refresher Training
  • Inspection Training
  • Project Manager Training
  • PV Training
  • Investigator Training (Site Training)

Trainings concepts are generated in cooperation with the client (client specific training). Training arrangements are worked out with the client in order to allow a maximum number of trainees to attend. All Training concepts are including workshops, assessment of training efficacy and training documentation.

Assessment and Establishment of efficient Quality Management Systems

  • Assessment of the QMS or current system within the company
  • Consultation in concepts and new structures
  • Risk Analysis and Recommendations